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Bupropion hydrobromide - Generic Drug Details
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What are the generic sources for bupropion hydrobromide and what is the scope of freedom to operate?
Bupropion hydrobromide
is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Bupropion hydrobromide has fifty-three patent family members in eighteen countries.
There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for bupropion hydrobromide
International Patents: | 53 |
US Patents: | 8 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 38 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 15 |
Clinical Trials: | 3 |
Patent Applications: | 72 |
Formulation / Manufacturing: | see details |
DailyMed Link: | bupropion hydrobromide at DailyMed |
Recent Clinical Trials for bupropion hydrobromide
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Sponsor | Phase |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Medical University of South Carolina | Phase 1 |
Valeant Pharmaceuticals International, Inc. | Phase 4 |
Generic filers with tentative approvals for BUPROPION HYDROBROMIDE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 522MG | TABLET, EXTENDED RELEASE; ORAL |
Start Trial | Start Trial | 174MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for bupropion hydrobromide
Drug Class | Aminoketone |
Mechanism of Action | Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors |
Physiological Effect | Increased Dopamine Activity Increased Norepinephrine Activity |
Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
APLENZIN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrobromide | 022108 | 2009-12-24 |
APLENZIN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrobromide | 022108 | 2009-09-28 |
APLENZIN | TABLET, EXTENDED RELEASE;ORAL | bupropion hydrobromide | 022108 | 2009-09-24 |
US Patents and Regulatory Information for bupropion hydrobromide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-001 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Valeant Pharms North | APLENZIN | bupropion hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 022108-002 | Apr 23, 2008 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for bupropion hydrobromide
Country | Patent Number | Estimated Expiration |
---|---|---|
Russian Federation | 2007147343 | Start Trial |
China | 101784266 | Start Trial |
World Intellectual Property Organization (WIPO) | 2008001341 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for bupropion hydrobromide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2316456 | 17C1058 | France | Start Trial | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
2316456 | 122017000109 | Germany | Start Trial | PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
2316456 | 132017000142109 | Italy | Start Trial | PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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